With the prevalence of AIDS it has become increasingly clear that there is a strong need for materials that will resist puncture and cuts during medical procedures, which generally expose medical personnel to sharp objects such as scalpels and needles for suturing and for injecting fluids. Although, AIDS has been the primary force behind the search for protection from blood borne infections, there is a host of such infections. Hepatitis and the Ebola infections are just two more examples of serious life threatening blood borne infections.
Surgical gloves are fabricated of an elastomeric polymeric material to act as a barrier to fluid flow and bacterial transmission between the patient and the care giver. They are most generally made from a thin layer of latex. Latex gloves allow the surgeon to retain a very high level of tactile sensitivity and ease of finger manipulation, but are easily cut by a scalpel or punctured by a needle.
There have been numerous attempts to fabricate a surgical glove that is cut and puncture resistant and yet retains characteristics necessary to perform delicate surgical procedures. In particular, such a glove must allow the wearer to feel the surface on which he or she is working. In other words, it must preserve tactile sensitivity. The glove must also be stretchable, bendable, and twistable. The universally used latex glove has all of these properties, except the property of cut and puncture resistance.
Various approaches have been tried to provide the surgical glove with today's additional requirement of cut and puncture resistance. For example, U.S. Pat. No. 4,742,578, to Seid, issued May 10, 1988 reinforces a surgical glove with an overlay of thin pliable material composed of a large number of tightly interlaced fibers or filaments of high strength. While this reportedly provides increased resistance to penetration, the margin of safety is far too low when faced with blood borne infections. U.S. Pat. No. 4,833,733, to Welch, issued May 30, 1989 incorporates a web of interwoven synthetic fibers such as nylon and aramid to provide some level of cut resistance, but due to the inherent porosity of the weave, it offers no puncture resistance. U.S. Pat. No. 4,864,661, to Gimbel, issued Sep. 12, 1989 purports to offer puncture resistance, but not cut resistance. Gimbel uses a woven fabric placed at high risk areas of the glove such as portions of the fingers. A woven fabric presents the possibility that a needle will be able to penetrate the fabric through the interstices formed by the intersecting fibers. U.S. Pat. No. 5,070,540, to Bettcher, issued Dec. 10, 1991 provides cut resistance using bundles of wire and fiber strands. The strands are situated throughout the entire glove. Bettcher does not purport to provide puncture resistance. The wire and fiber strands limit flexibility of the glove, a major requirement of a surgeon. U.S. Pat. No. 5,317,759, to Pierce, issued Jun. 7, 1994 is a glove with pillars extending perpendicular to the plane of the glove between outer and interior glove layers of a latex type material. The pillars reduce the chance of a suture needle piercing the glove, since, as the suture angles through the glove, it will most likely contact a pillar. This glove design suffers from the inability to stop a hypodermic needle piercing the glove at an angle close to perpendicular to the plane of the glove material. It also is not cut resistant and the rigid embedded pillars substantially reduce flexibility of the glove. U.S. Pat. No. 5,368,930, to Samples, issued Nov. 29, 1994 is an elastomeric sheet material with enhanced puncture resistance. Imbedded in the material are plate-like non-elastomeric particles. This material suffers from at least two deficiencies. It is not cut proof and the embedded plates make the material very stiff. U.S. Pat. No. 5,407,612, to Gould, issued Apr. 18, 1995 is similar to the Samples material. It has flat plates oriented parallel to the elastomeric glove material and embedded in the glove material. This has the unfortunate effect of acting like reinforcing rods in cement. The glove as a result becomes inflexible. While there have been other attempts to make a cut proof or a puncture proof surgical glove, they also fail to meet the unique combination of characteristics required by the surgical process.
As pointed out in this section by the review of certain patented gloves and glove material, there have been attempts to solve the major need of an effective and reliable barrier material to body fluid transmission between the health professional and the patient. Yet, this need must be met while maintaining the health professional's ability to carry on his or her task of surgery, drawing bodily fluids, or other such activity. Each of the currently available gloves or barrier material lacks one or more of the necessary properties for an effective surgical barrier. The properties include: (1) cut resistance, (2) puncture resistance, (3) flexibility, (4) bendability, (5) twistability, (5) stretchability, (6) ability to maintain the user's tactile sensitivity, and (7) an effective barrier to transmission of body fluids.
The object of this invention is to provide an effective cut and puncture resistant barrier, for use in conjunction with conventional fluid barrier materials, that has all of the necessary properties for use in the medical and other fields where the transmission of body fluids between the care-giver and the patient must be eliminated.